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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device motor, surgical instrument, ac-powered
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGEY
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Device inoperable 280
Device operates differently than expected 110
Mechanical jam 110
Unintended system motion 103
Fail-safe mechanism issue 101
Failure to power-up 34
Overheating of device or device component 29
Sticking 29
Fluid leak 24
Break 22
Loss of power 21
Noise, Audible 19
Loose or intermittent connection 18
Mechanical issue 14
Device stops intermittently 12
Battery issue 11
Failure to charge 11
Detachment of device component 10
Leak 10
Power source issue 10
Temperature issue 10
Defective item 8
Device displays error message 7
Material separation 7
Defective component 7
Component falling 7
Blockage within device or device component 7
Vibration 6
Connection issue 6
Failure to shut off 6
Naturally worn 5
Slippage of device or device component 5
Difficult to position 5
Power Conditioning Issue 4
Difficult to insert 4
Air leak 4
Component missing 4
Detachment of device or device component 4
Physical resistance 4
Fitting problem 3
Output below specifications 3
Smoking 3
Failure to Adhere or Bond 3
Bent 3
Component incompatible 3
Fracture 3
Device remains activated 3
Crack 2
Unintended ejection 2
Self-activation or keying 2
Device contamination with blood or blood product 2
Failure to calibrate 2
Positioning Issue 2
Torn material 2
Unintended movement 1
Misassembled by Users 1
Not Applicable 1
Device handling issue 1
Pressure issue 1
Moisture or humidity problem 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Material integrity issue 1
Device or device component damaged by another device 1
Difficult to open or close 1
Structural problem 1
Difficult or delayed activation 1
Improper or incorrect procedure or method 1
Unraveled material 1
Inappropriate shock 1
Circuit Failure 1
Device clogged 1
Application interface becomes non-functional or program exits abnormally 1
Decoupling 1
Decrease in suction 1
Unintended energization 1
Disassembly 1
Failure to discharge 1
Disconnection 1
Fail-safe design failure 1
Retraction problem 1
Material rupture 1
Hole in material 1
Melted 1
Moisture damage 1
Device emits odor 1
Total Device Problems 1158

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 1 0 0 0 3 1 1 0
Class III 0 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. dba ConMed Linvatec III Mar-06-2013
2 Linvatec Corp. dba ConMed Linvatec II Jul-17-2010
3 MEDICAMAT S.A. II Mar-04-2014
4 Nico Corp. II Jun-21-2016
5 Nico Corp. II Sep-15-2015
6 Synthes U S A II Sep-21-2008
7 The Anspach Effort, Inc. II Jun-25-2014
8 The Anspach Effort, Inc. II Jan-06-2014

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